A breakthrough cancer pain spray will begin hitting the UK market.
PecFent, a fentanyl pectin nasal spray, will now be available in the UK. The drug was granted marketing authorization by the European Medicines Agency.
PecFent is indicated for the treatment of breakthrough cancer pain (BTCP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. The spray is manufactured by Archimedes Pharma Ltd., an international specialty pharma company.
BTCP affects 24 to 95% of all cancer patients with pain, despite background pain medication. It is characterized by episodes of pain that can reach maximum intensity within five minutes, and typically last 30 to 60 minutes. BTCP is often sudden and unpredictable and occurs in people who are already taking strong opioid pain killers for cancer pain.
PecFent contains the highly potent opioid analgesic fentanyl. It uses the Archimedes Pharma nasal drug delivery system PecSys to deliver fentanyl in a rapid but controlled manner. The product is designed to help match the time course of the typical breakthrough pain episode.
Fentanyl may cause serious adverse effects such as tolerance or dependence, and respiratory depression and bradycardia. Only patients who are already on established maintenance opioid therapy and are tolerant to opioids may use the product. Patients must be closely monitored in the titration process.
In two randomized, controlled, double-blind, phase 3 clinical trials, PecFent demonstrated evidence of onset of pain relief as early as five minutes, as well as clinically meaningful pain relief from 10 minutes. The use of PecFent in the treatment of breakthrough cancer pain was associated with the occurrence of adverse events typical of opioid medication in this population.
“I'm delighted that we're in a position where we can make PecFent available to cancer patients in the UK and offer them and the healthcare professionals who care for them a real opportunity to improve the management of their cancer pain,” said Jeffrey H. Buchalter, president and chief executive officer of Archimedes Pharma, in a press release. “This has been a development programme taking many years of hard work and investment from the company, and the approval of our lead product marks a significant milestone for Archimedes Pharma in our ongoing commitment to develop and market innovative products throughout Europe.”
Professor Marie Fallon, Edinburgh Cancer Research Centre, said, in a press release: "BTCP is a challenge for current treatment options as it can be so rapid in onset, of short duration and severe to excruciating in intensity. The launch of PecFent is long awaited and promises another important treatment option for patients with this devastating condition. I personally look forward to being able to prescribe PecFent, as I have patients who I know will benefit from this new product, which provides a real advance in the delivery of breakthrough cancer pain relief."
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